What is Palonosetron Accord and what is it used for?
Palonosetron Accord is a medicine used to prevent nausea and vomiting associated with chemotherapy (cancer therapy).It is used in adults and children aged 1 month and over undergoing chemotherapy with medicines that have high (such as cisplatin) or moderate (such as cyclophosphamide, doxorubicin or carboplatin) potential to cause nausea and vomiting.
Palonosetron Accord contains the active substance palonosetron. It is a 'generic medicine'. This means that Palonosetron Accord is similar to a 'reference medicine' already authorized in the European Union (EU) called Aloxi. For more information on generic medicines, see the questions and answers by clicking here.
How is Palonosetron Accord used?
Palonosetron Accord should only be administered before chemotherapy. It is available as a solution for injection or infusion into a vein (drip) and should be given by a healthcare professional approximately 30 minutes before the start of chemotherapy. The recommended dose in adults is 250 micrograms, injected into a vein over a period of 30 seconds. To increase efficacy, it can be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting). In children, the solution should be given as an infusion into a vein over 15 minutes at the dose. 20 micrograms per kilogram of body weight.
The medicine can only be obtained with a prescription.
How does Palonosetron Accord work?
The active substance in Palonosetron Accord, palonosetron, is a '5HT3 antagonist', which means that it prevents a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from binding to the 5HT3 receptors in the gut. When 5HT binds to these receptors, it usually causes nausea and vomiting.By blocking these receptors, Palonosetron Accord prevents the nausea and vomiting that often occur after chemotherapy.
What benefit has Palonosetron Accord shown during the studies?
The company presented data on palonosetron from the scientific literature. No further studies were needed as Palonosetron Accord is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
What is the risk associated with Palonosetron Accord?
Because Palonosetron Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Palonosetron Accord been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Accord has been shown to be comparable to Aloxi. Therefore, the CHMP considered that, as in the case of Aloxi, the benefits outweigh the identified risks and recommended that Palonosetron Accord be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Palonosetron Accord?
A risk management plan has been developed to ensure that Palonosetron Accord is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Palonosetron Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Palonosetron Accord
For the full version of the Palonosetron Accord EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports.
For more information about Palonosetron Accord therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
The information on Palonosetron Accord published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
